The approval was based on data from a phase 3 study that evaluated Trikafta in 66 children 6 to 11 years of age with CF who were either homozygous for the F508del mutation or heterozygous for the F508del mutation and 1 minimal function mutation.
Positive topline results were announced from two phase 3 studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine, in pediatric patients for the prevention of invasive pneumococcal disease.
The BLA submission is supported by data from the PATHFINDER clinical program.
Bamlanivimab is a potent neutralizing IgG1 monoclonal antibody directed against the spike protein of severe acute respiratory syndrome coronavirus 2.
High flow nasal cannula oxygen significantly reduced intubation and subsequent invasive mechanical ventilation, but did not affect case fatality in patients with COVID-19 admitted to the ICU for acute respiratory failure.
Expired or previously used and sterilized N95 respirators can be used when new N95 respirators are unavailable during the COVID-19 pandemic.
The Advisory Committee on Immunization Practices encourages all Americans to receive the flu vaccine between September and October.
Remdesivir is an investigational nucleotide analogue with broad-spectrum antiviral activity.
A robot-assisted ultrasound system was able to remotely assess cardiopulmonary features in patients with COVID-19.
Researchers explored the question of the seasonality of SARS-CoV-2 by reviewing evidence related to viral viability, transmission, ecological patterns, and observed epidemiology of COVID-19 in the Southern Hemispheres’ summer and early fall.
